Product Overview Product feature summary

• The Test Kits have not been FDA cleared or approved.

• The Test Kits have been authorized by the FDA under an EUA for non-prescription home use.

• Emergency use of these Test Kits is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

• The Test Kits have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.LI>

Specifications Product specifications and dimensions

• Brand
  Cue
• CLIA Classification
  OTC
• For
  Home and Over The Counter (OTC) Use
• Item
  Test Kit
• Item Type
  COVID-19

Catalog Description As seen in our print catalog

The Cue™ COVID-19 Test is a molecular in vitro diagnostic test for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens collected with the Cue Sample Wand. Intended for use in adults (self-swabbing) or children ≥2 years of age (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19. Authorized for nonprescription home use. Utilizes isothermal nucleic amplification technology. Must be used with the Cue Health Monitoring System (Cue Cartridge Reader) and the Cue Health Mobile App.